Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1568 in Healthy Adult Volunteers

November 5, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

An Open-label, Randomized, 2x4 Crossover Study to Compare the Pharmacokinetics and Safety Following Administration of DWJ1568 and DWC202215 in Healthy Volunteers

This study aims to compare the pharmacokinetics and safety following administration of DWJ1568 and DWC202215 in healthy volunteers

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study design is a Randomized, Open-label, Oral, Single-dose, Four-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUCt of DWJ1568 and DWC202215. Secondary endpoints were AUCinf, Tmax, t1/2 of DWJ1568 and DWC202215.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: MunJung Bae, MD, Ph D
  • Phone Number: 070-4665-9174
  • Email: m4222@newyjh.com

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • over 19 year old

Exclusion Criteria:

  • Galactose intolerance
  • Lapp lactase deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWJ1568
Drug: DWJ1568
One tablet of DWJ1568
Active Comparator: DWC202215
Drug: DWC202215
One tablet of DWC202215

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax,ss of DWJ1568 and DWC202215
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt of DWJ1568 and DWC202215
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.

Secondary Outcome Measures

Outcome Measure
Time Frame
AUCinf of DWJ1568 and DWC202215
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.
Tmax of DWJ1568 and DWC202215
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.
AUCt/AUCinf of DWJ1568 and DWC202215
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.
t1/2 of DWJ1568 and DWC202215
Time Frame: At pre-dose (0 hour), and post-dose 0 to 72 hour.
At pre-dose (0 hour), and post-dose 0 to 72 hour.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 9, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

October 23, 2023

First Submitted That Met QC Criteria

November 5, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DWJ1568101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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